A phase II trial of a transmucosal herbal patch for the treatment of gingivitis

BackgroundSystemic treatments for gingivitis frequently are inadequate for controlling specific sites of severe gingival inflammation. The authors conducted a study to test site-specific therapy using a transmucosal herbal periodontal patch (THPP) that was impregnated with plant extracts reported to reduce inflammatory response.MethodsThe study was a single-center, randomized, placebo-controlled, double-masked, longitudinal phase II trial involving participants with clinically diagnosed gingivitis. Participants who were enrolled in the study received either THPPs or placebo patches (PP) for three days. The authors evaluated gingival inflammation visually using the gingival index (GI) and by measuring gingival crevicular fluid β-glucuronidase (BG) enzymatic activity at baseline (day one) and on days two, four, eight and 15.ResultsThe authors randomly assigned 53 participants to receive the THPP or the PP. Participants who received the THPPs had a greater reduction in mean GI scores than did those who received the PPs. This finding was significant on days four and 15. The percentage of participants whose GI scores decreased by one or more was higher among those receiving the THPP than among those receiving the PP, as assessed on days four and 15. The average decrease in BG levels (fluorescence units) for participants receiving the THPP was significantly greater on days four and eight than they were for those receiving the PP. No serious adverse events were associated with the use of the THPP.ConclusionsTopical treatment by means of the THPP may be effective and safe in reducing topical gingival inflammation. Further studies are needed to confirm these findings and determine the best method for administering the THPP and the appropriate dosing.Clinical ImplicationsSite-specific treatment of gingival inflammation is feasible and could be used as an adjunct for systemic therapeutic interventions.     

Correlation analysis for clinical and gingival crevicular fluid parameters at anatomically related gingival sites

This study was designed to evaluate the relationship of certain clinical and biochemical measures of periodontal pathology at anatomically related gingival sites. The maxillary first molar--second bicuspid region was studied in patients with gingivitis and periodontitis. The mesiobuccal site on the first molar was compared to the mesiopalatal and direct buccal sites on the molar and the distobuccal site on the second bicuspid. Probing depth, attachment level, gingival index, gingival crevicular fluid (GCF) volume, and GCF levels of the lysosomal enzyme B-glucuronidase (BG), the cytoplasmic enzyme lactate dehydrogenase, IgG and the protease-inhibitor alpha-2-macroglobulin were studied. For the 3 anatomical pairs that were analyzed, the correlation coefficients for the GCF constituents were generally higher than the correlations for the clinical parameters. The mean correlations for the GCF constituents were higher for the periodontitis patients as compared to the gingivitis patients. For the periodontitis patients, BG activity was correlated at adjacent proximal sites, approached significance at adjacent papillary sites, but was not significantly correlated at adjacent facial-proximal sites. This data suggests that sampling of BG activity from a mesiobuccal site provides information about the anterior papillary unit. In contrast, IgG in GCF collected from the mesiobuccal site on the first molar was significantly correlated with the total IgG in the 3 other sites.(ABSTRACT TRUNCATED AT 250 WORDS)     

Changes in gingival crevicular fluid levels of immunoglobulin A following therapy: association with attachment loss.

BACKGROUND: In previous studies, we demonstrated that increased levels of immunoglobulin A (IgA) in gingival crevicular fluid (GCF) may be "protective", while increased levels of the polymorphonuclear lysosomal enzyme, beta-glucuronidase, in GCF were associated with increased risk of disease activity. In this study, we examined the effect of scaling and root planing (SRP) on the levels of beta-glucuronidase, IgG, and IgA in GCF over a 24-week period and compared these to clinical attachment loss (CAL). METHODS: Twenty-nine patients with periodontal disease were examined for attachment level, probing depth, plaque, and bleeding on probing at 6 sites per tooth. GCF was collected from the mesial aspect of all teeth excluding third molars and analyzed for beta-glucuronidase, IgG, and IgA. After baseline data were collected, each patient received SRP, and GCF was collected again at 2, 4, 6, 8, 12, and 24 weeks post-SRP while clinical data were obtained at 4, 8, 12, and 24 weeks. In addition, we analyzed whether the magnitude of the IgA response to SRP would affect the rate of periodontal disease progression by examining GCF IgA levels at 2 time intervals: 2 to 4 weeks post-SRP and 6 to 12 weeks post-SRP. RESULTS: Seventeen patients (58.6%) exhibited at least 1 site losing > or =2.5 mm of CAL during the 24-week study. Beta-glucuronidase in GCF was significantly decreased at 2 weeks following SRP and then demonstrated a gradual increase throughout the study period. Levels of IgA in GCF significantly increased following SRP, reaching a peak at 6 weeks and then gradually decreasing throughout the study. Furthermore, we found an inverse relationship between GCF IgA levels at 6 to 12 weeks post-SRP and the occurrence of CAL. CONCLUSIONS: These results support the hypothesis that maintenance of high levels of IgA in GCF may be "protective" against periodontal attachment loss. Furthermore, levels of beta-glucuronidase appear to be a more sensitive indicator of gingival inflammation than clinical measures.